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Vax Facts Human Papillomavirus (HPV): Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV

NCT ID: NCT01143142

Last Updated: 2014-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-10-31

Brief Summary

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The goal of this study is to determine whether a two-page print brochure that delivers individually tailored educational messages about the Human papillomavirus (HPV) vaccine increases HPV vaccine-hesitant mothers' intentions to have their adolescent daughters vaccinated against HPV.

Detailed Description

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This will be a randomized controlled intervention trial for HPV vaccine-hesitant mothers of adolescent (ages 11-15 years old) girls. Mothers will complete a three-item measure that assesses their baseline intentions for having their adolescent daughter vaccinated against HPV. Mothers will then fill out a short, computer-based survey that assesses demographic factors, prior experience with HPV-associated illnesses and views about a variety of potential barriers to HPV vaccination. Following the survey, the intervention group (40 mothers) will receive a two-page print brochure that uses their survey data to generate the brochure such that it addresses each mother's top three concerns about the HPV vaccine. The control group (40 mothers) will receive a generic, two-page brochure that is similar in appearance to the intervention, but contains only untailored, generic information about the vaccine. HPV vaccination intention will be assessed a second time after reading the brochure, using the same three-item measure as before the survey. The vaccine administration records of the adolescent daughters of these mothers will be accessed three months after mothers' participation in the study to assess whether any HPV vaccine doses were provided.

Conditions

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Human Papillomavirus Prevention

Keywords

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Human papillomavirus HPV Prevention Tailoring Persuasive communication Adolescent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Tailoring

Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.

Group Type EXPERIMENTAL

Computer-based tailoring system

Intervention Type BEHAVIORAL

Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure.

Untailored information

Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.

Group Type ACTIVE_COMPARATOR

Computer-based tailoring system

Intervention Type BEHAVIORAL

Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure.

Interventions

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Computer-based tailoring system

Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Mother is greater than or equal to 18 years of age
* Mother has a daughter who is between the ages of 11-15 years
* Daughter has not received any doses of the HPV vaccine
* When asked to describe how she feels about getting her daughter vaccinated against HPV in the next six months, mother responds "I don't want her to get vaccinated" or "I'm unsure if I want her vaccinated."

Exclusion Criteria

* Cannot read/speak English
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Amanda Dempsey

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amanda Dempsey, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Child Health Evaluation and Research Unit

Locations

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UMHS Outpatient Pediatrics

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Centers for Disease Control and Prevention (CDC). National, state, and local area vaccination coverage among adolescents aged 13-17 years--United States, 2008. MMWR Morb Mortal Wkly Rep. 2009 Sep 18;58(36):997-1001.

Reference Type BACKGROUND
PMID: 19763075 (View on PubMed)

Chesson HW, Blandford JM, Gift TL, Tao G, Irwin KL. The estimated direct medical cost of sexually transmitted diseases among American youth, 2000. Perspect Sex Reprod Health. 2004 Jan-Feb;36(1):11-9. doi: 10.1363/psrh.36.11.04.

Reference Type BACKGROUND
PMID: 14982672 (View on PubMed)

Dempsey AF, Abraham LM, Dalton V, Ruffin M. Understanding the reasons why mothers do or do not have their adolescent daughters vaccinated against human papillomavirus. Ann Epidemiol. 2009 Aug;19(8):531-8. doi: 10.1016/j.annepidem.2009.03.011. Epub 2009 Apr 25.

Reference Type BACKGROUND
PMID: 19394865 (View on PubMed)

Dempsey A, Cohn L, Dalton V, Ruffin M. Patient and clinic factors associated with adolescent human papillomavirus vaccine utilization within a university-based health system. Vaccine. 2010 Jan 22;28(4):989-95. doi: 10.1016/j.vaccine.2009.10.133. Epub 2009 Nov 17.

Reference Type BACKGROUND
PMID: 19925899 (View on PubMed)

Dempsey AF, Zimet GD, Davis RL, Koutsky L. Factors that are associated with parental acceptance of human papillomavirus vaccines: a randomized intervention study of written information about HPV. Pediatrics. 2006 May;117(5):1486-93. doi: 10.1542/peds.2005-1381.

Reference Type BACKGROUND
PMID: 16651301 (View on PubMed)

Gust D, Brown C, Sheedy K, Hibbs B, Weaver D, Nowak G. Immunization attitudes and beliefs among parents: beyond a dichotomous perspective. Am J Health Behav. 2005 Jan-Feb;29(1):81-92. doi: 10.5993/ajhb.29.1.7.

Reference Type BACKGROUND
PMID: 15604052 (View on PubMed)

Hawkins RP, Kreuter M, Resnicow K, Fishbein M, Dijkstra A. Understanding tailoring in communicating about health. Health Educ Res. 2008 Jun;23(3):454-66. doi: 10.1093/her/cyn004. Epub 2008 Mar 17.

Reference Type BACKGROUND
PMID: 18349033 (View on PubMed)

Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007 Mar 23;56(RR-2):1-24.

Reference Type BACKGROUND
PMID: 17380109 (View on PubMed)

Other Identifiers

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P50CA101451

Identifier Type: NIH

Identifier Source: secondary_id

View Link

149891

Identifier Type: -

Identifier Source: org_study_id